DRAFT RULES Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.— The State Licencing Authority shall appoint Licensing Authorities for the purpose of issuing Registration Certificate in this Part for such areas as may be Any person who intends to sell, stock, exhibit …
CDSCO Update for Selling Medical Devices in IndiaRead More »
IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION Medical devices have a vital role in providing better diagnosis, prevention, Screening, monitoring, and treatment of various diseases. The COVID -19 pandemic challenge has shown the necessity to have accurate diagnostics and a stringent framework for the in vitro medical devices (IVDs). IVDs are biological tests that can detect …
EUROPEAN IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATIONRead More »
The drug -device combination (DDC) products are the therapeutic or diagnostic products that combine drugs, devices or biological products which leads to safe and effective treatments. It helps in targeted drug delivery, localized drug administration and individualized medicine therapy. With the advancement in technology drug-device combination products have developed a unique form of medicinal products that has cardiovascular, …
IMPLICATIONS FOR DRUG-DEVICE COMBINATION PRODUCTS: MDR ARTICLE 117Read More »
Personal protective equipment (PPE) EUAs FDA refers to shielding apparel, helmets, gloves, face shields, goggles, respirators or different system designed to shield the wearer from injury or the spread of infection or contamination. To assist address concerns about availability throughout the COVID-19 pandemic, the FDA has issued Emergency Use Authorizations (EUAs) for sure PPE products …
A successful and safe medical device development is an essential element of any medical device manufacturer. Developing the right medical device needs repetition of processes to ensure the quality of the device to prevent the future risk of failure of the product. A medical device company strives hard to improve and meet stringent regulatory requirements …
An Approach Towards ( To) Corrective Action Request with Medical Device Suppliers.Read More »
医疗器械风险管理安全和质量are non-negotiable in the medical device industry. Risk management at early stage, Intellectual Property protection, design quality control, prioritizing, understanding and buying the insurance helps in managing the business risk as a medical device company. Medical device risk management for safety makes it easy to understand the risk …
米edical Device Risk Management As Non-Negotiables for Managing Business RiskRead More »
EU MDR compliance for Legacy Devices Legacy devices are the medical devices, active implantable medical devices and in vitro diagnostic devices that are placed in the market with valid certificates issued from Medical Devices Directive (MDD) or Active Implantable Medical Device (AIMD). The valid CE (Conformité Européenne) marking certificates are issued according to Directive 93/42/EEC, …
European Regulators Offer New MDR Compliance Guidance For Legacy Medical DevicesRead More »
Saudi Arabia SFDA Guidance on UDI A wide range of medical devices are available in the market. The rising concerns related to medical devices like patients’ safety and supply chain management has forced the introduction of a single, unique, globally harmonized identification system for every device. UNIQUE IDENTIFICATION IDENTIFIER The US FDA has established the …
Extends Deadlines for Saudi Arabia SFDA Guidance on UDIRead More »
Product Development Medical Devices The medical device sector has a remarkable impact on the healthcare industry and is expanding its role in the global economy. It is significantly evolving over the span of years. Advancement in scientific knowledge and engineering technology has accelerated the innovation in medical devices. Medical device technology is interdisciplinary and individuals …
The Impact of Change on Medical Device Medical technology and medical device companies have great impact on health care sector. To pursue change to any technology is to keep evolving the needs of the world. Unlike others, medical device company has to make changes to their device constantly. The advancement in technology or process allows …
How to Assess the Impact of Change on Medical DeviceRead More »